Cardiovascular Risk
Conditions
Brief summary
The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol.
Detailed description
The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol. To do this, volunteers consume the product under study or placebo for three months. Tests will be performed before and after ingestion of the product.
Interventions
DIETARY_SUPPLEMENTdietetics
90 days of consumption
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Not belonging to the group of individuals considered as priorities by the Third Joint Task Force for the prevention of cardiovascular diseases due to high risk. 2. Present total cholesterol figures greater than 200 milligrams / deciliter and / or low density cholesterol figures greater than 130 milligrams / deciliter so that after applying the cardiovascular risk table (SCORE) they present a current risk of less than 5% of suffer an ischemic event in a period of 10 years, being without pharmacological treatment. 3. Present several cardiovascular risk factors with cholesterolemia figures close to 200 milligrams / deciliters and / or low density cholesterol figures close to 130 milligrams / deciliters.
Exclusion criteria
1\. chronic or terminal illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | The change in systolic and diastolic blood pressure is observed after three months of intake of the product under investigation | The systolic and diastolic blood pressure was measured with an OMRON oscilimétrilo sphygmomanometer |
| Biochemistry and blood count | The change is observed after three months of intake of the product under investigation | the hematological profile is analyzed with the Horiba ABX Oentra 80 analyzer. Biochemical profile with the ILAB 600 analyzer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | The change is observed after three months of intake of the product under investigation | Weight and height are combined for BMI report in kg / m \^ 2 |
| Perimeters | The change is observed after three months of intake of the product under investigation | Measured in cm. Waist, hip, waist / hip index, relaxed biceps, contracted biceps, medial thigh, twin or calf. Folds (mm) (tricipítal, subscapular, suprailiac anterior or supraspinal, abdominal, quadricipital or thigh, leg or calf medial, bicipital, iliocrestal). Diameters (cm) (radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol). |
| Weight | The change is observed after three months of intake of the product under investigation | Measured in Kg. |
| Diameters | The change is observed after three months of intake of the product under investigation | Measured in cm. Radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol. |
| Nutritional record | Measurements are made at the beginning and after 90 days of product consumption. | Volunteers record dietary intake for three days in a notebook. They will describe the amount of food they consume in grams in order to assess changes in intake during the clinical trial. |
| Folds | The change is observed after three months of intake of the product under investigation | Measured in mm. Tricipítal, subscapular, suprailiac anterior or supraspinal, abdominal, quadricipital or thigh, leg or calf medial, bicipital, iliocrestal. Diameters (cm) (radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol). |
| Height | The change is observed after three months of intake of the product under investigation | Measured in cm. |
Countries
Spain
Outcome results
None listed